This follow-up report is being submitted to relay additional information.The rosa knee system log files were sent back for investigation and analyzed by a subject matter expert (sme).The logs do not allow to confirm which poly size was used, however the two validations of the tibia confirmed the reported over-resection.The functionality and accuracy of rosa knee platform was verified by a field service engineer (fse).The fse did not find anything off with the system.Review of dhr identified no deviations or anomalies related to the reported event.A definitive root cause could not be determined with the information available.Through reassessment of this event, it was identified as being reported in error.Reportability is based on harm/intervention required and not a specific resection level.No patient impact, medical intervention, or surgical intervention was reported for this event; therefore, the event does not meet the requirements for a serious injury/adverse event and is considered not reportable.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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